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A Study Evaluating the Efficacy and Safety of Sildenafil in Patients With Erectile Dysfunction Receiving Hemodialysis

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00654017
First received: March 31, 2008
Last updated: April 2, 2008
Last verified: April 2008

March 31, 2008
April 2, 2008
October 2002
Not Provided
Response to questions 3 (frequency of penetration) and 4 (frequency of maintained erection) of the International Index of Erectile Function (IIEF). [ Time Frame: Baseline and Week 10 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00654017 on ClinicalTrials.gov Archive Site
  • rate of successful sexual intercourse (number of attempts at sexual intercourse, number of successful attempts and percentage of attempts that were successful) [ Time Frame: Baseline to Week 10 ] [ Designated as safety issue: No ]
  • response to Partner's Satisfaction Questionnaire (optional) [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
  • total Score of Quality of Life and erectile dysfunction questionnaire [ Time Frame: Baseline and Week 10 ] [ Designated as safety issue: No ]
  • monitoring of adverse events (AEs) and measurement of sitting blood pressure and heart rate [ Time Frame: Baseline, and Weeks 2, 4, 6, and 10 ] [ Designated as safety issue: Yes ]
  • response to Question 1 of the Global Efficacy Assessment Question [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
  • responses to questions of the IIEF [ Time Frame: Baseline and Week 10 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study Evaluating the Efficacy and Safety of Sildenafil in Patients With Erectile Dysfunction Receiving Hemodialysis
Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Flexible, Titration Dose Administered on an As Needed Basis (PRN) to Evaluate the Efficacy and the Safety of Sildenafil for the Treatment of Erectile Dysfunction in Male Patients on Hemodialysis

The study was done to evaluate the efficacy, safety, and tolerability of orally administered sildenafil taken as needed about one hour before sexual activity after a 10-week period in male outpatients with erectile dysfunction and severe renal failure who were on hemodialysis.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Erectile Disfunction
  • Hemodialysis
  • Drug: placebo
    Placebo comparator to be given per protocol.
  • Drug: sildenafil
    oral sildenafil citrate at an initial dose of 25 mg, which could have been up-titrated to 50 mg at Visit 3 based on the patient's efficacy, safety and tolerability responses; at Visits 4 and 5, the dose could remain the same, be increased to 100 mg, or decreased to 25 mg depending on the safety, efficacy, and tolerability
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Active Comparator: sildenafil
    Intervention: Drug: sildenafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2005
Not Provided

Inclusion Criteria:

  • Included patients had been in a stable relationship with a female partner for at least 6 months
  • A diagnosis of renal failure, with creatinine clearance ≤10 ml/min; been under hemodialysis for at least 6 months prior to the screening period, and a clinical diagnosis of erectile dysfunction (ED) as confirmed by International Index of Erectile Function (IIEF-5) score of <21 and defined as an "incapacity to obtain and/or maintain an erection sufficient for a satisfactory sexual performance".

Exclusion Criteria:

  • Patients in regular use of nitrates or nitric oxide donor drugs, or have received a prescription to use these substances in any formulation
  • Patients with genital anatomic malformation that may significantly impair erection (e.g., serious penile fibrosis)
  • Patients with other sexual disorders (e.g., hypoactive sexual desire) considered as a primary diagnosis, with a coexisting ED diagnosis, including patients receiving anti-androgenic therapy whose libido has not been preserved; patients receiving hormonal replacement therapy for at least 6 months, or whose dose has not been stabilized within the last 6 months before the study screening period
  • Patients with diabetes mellitus presenting poor control of their diabetes and/or proliferate diabetes retinopathy.
Male
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00654017
A1481076
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP